MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BIOMET CC CRUCIATE TRAY 63MM; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/14/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated report: 0001825034-2020-02711.Concomitant medical product: vngd ant stblzd brg 10x63, item# 189020, lot# 075590.Report source - (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation at this time due to circumstances related to covid 19.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that a patient was revised approximately five weeks post implantation due to pain and locking bar backing out.During the primary case proper seating of the poly ethylene insert was ascertained.However, after surgery the patient was feeling pricking pain over medial aspect of left knee.Post op x-ray showed the locking pin of insert was backing out.There is no additional information at this time.
Additional Manufacturer Narrative
This follow-up is being submitted to relay additional information.Updated: b4, b5, g4, g7, h1, h2, h3, h6, and h10.Corrected: d1, d4, g5.No product was returned; therefore, visual and dimensional evaluations could not be performed.Photograph taken during the surgery confirms that the locking bar has backed out.Medical records are not provided.Letter provided by surgeon states that patient underwent total knee arthroplasty and came back one-month post op with severe pain over medial aspect of knee.When examined and investigated, infection was ruled out but the x-ray revealed backing out of locking pin resulting in the patient being revised.Device history record (dhr) was reviewed for deviations and/ or anomalies with no related deviations / anomalies identified.Root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.D4: udi#: (b)(4).The event is confirmed with product received.Visual inspection of the returned locking bar exhibits wear consistent with signs of being implanted.Sem analysis revealed that even though the examined locking bar contact mark and deformation observations are consistent with the bars not being fully engaged with the tibial tray lugs, it cannot be determined with certainty whether the reported locking bar dissociations occurred due to improper insertions.A more definitive conclusion would require analysis of not just the locking bars, but also of the mating tibial trays as well as the implanted bearings.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: BIOMET CC CRUCIATE TRAY 63MM
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10256845
• Report Number: 0001825034-2020-02710
• Device Sequence Number: 16854602
• Product Code: JWH
• UDI-Device Identifier: 00880304231917
• UDI-Public: (01)00880304231917
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K171054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 141231
• Device Lot Number: J6257244
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/07/2019
• Supplement Date Received by Manufacturer: 07/14/2020; 01/07/2021
• Initial Report FDA Received Date: 07/10/2020
• Supplement Report FDA Received Date: 07/16/2020; 01/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention